FDA Removes Black Box Warning From Smoking Cessation Drug

The FDA has removed its black box warning from the label of the smoking-cessation drug Chantix (varenicline) warning about the risk of serious neuropsychiatric events including depression and suicide.

The decision was based upon an FDA review of data from a clinical trial involving approximately 8000 smokers with and without a history of psychiatric disorder, indicating that although still present, the risk of these mental health side effects is lower than previously believed.
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The FDA has also decided to update its boxed warning for Zyban (bupropion), removing language describing serious mental health side effects from the label.

Both labels will be updated to describe side effects on mood, behavior, or thinking to include results from the clinical trial.

The FDA stressed that the risk of these mental health side effects is especially present in individuals currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia.

—Michael Potts

Reference:

FDA. Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - mental health side effects revised. December 16, 2016. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533517.htm. Accessed December 19, 2016.